We understand the regulatory burdens imposed upon drugs and biologics. Our nimble team advances both early stage pre-commercialization companies and multinational organizations through these challenging regulatory hurdles.

Our flexibility allows us to support simple to high-risk, complex implantable devices. We support the development, validation, design and regulatory submission of your device with the appropriate regulatory body.

We strategically partner with CROs, CMOs, laboratories, research sites, and others to provide timely solutions. We understand the pressure of meeting your clients’ needs, and our responsive team builds strong relationships to help our partners win.

We wouldn’t be where we are today without Pearl Pathways. Their advisors’ expertise and flexibility helps keep us on track to overcome obstacles and meet deadlines. They have been there with us through the various ups and downs of our pharma startup.

After the US Food and Drug Administration (FDA) released its 11-part biosimilar action plan, FDA has now announced that it will hold a public hearing to gather input “on how it can facilitate the development of biosimilars and ensure they enter the market...

On February 21, 2018 the US Food and Drug Administration (FDA) published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices. The new rule states that sponsors and applicants conducting clinical...

On July 11, 2018 the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) offered 6 new draft guidance documents on human gene therapies. The documents offer a look at what it expects from an industry that is becoming...

Pearl Pathways is a comprehensive life science product development services company. Every day we strive to provide our customers top quality service, unyielding ethics, and efficient services through our team of experts. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Our full-service central IRB supports all aspects of human research.